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BD (Becton, Dickinson and Company) Quality Engineer II in Tempe, Arizona

Job Description Summary

Job Description

Primarily responsible for providing Quality Engineering support to Sustaining projects (e.g., MDR).This position supports product leadership and risk management of new product development.

  • Leads development of risk assessments

  • Supports component qualifications, design validation / verification and process validation

  • Leads basic level product investigations

  • Leads test method validations

  • Ability to make and present risked based decisions

  • Assess product changes against product design

  • Supports translation of design inputs into manufacturing control plans

  • Quality engineering representation on Product Development Teams.

  • Participate and provide input to training on department/division procedures, and policies.

  • Participate in project planning, budgeting, scheduling and tracking.

  • Support internal and external supplier audits.

  • Develop and implement procedures to comply with corporate and industry standards.

  • Provide support to the regulatory department in writing technical submissions.

  • Provide positive example and actively promote compliance to division, corporate and industry standards.

  • Maintain a professional working relationship with internal and external customer and support staff.

  • Prepare and present project updates and technical discussions.

  • Support "Voice of the Customer" identification and translation into design inputs.

  • Knows how products are used and impact the user(s) so that risk can be managed effectively.

  • Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc…)

  • Working knowledge in some of the related business technologies.

  • Ability to develop solutions with moderate business impact.

  • Advanced statistical and risk assessment techniques.

  • Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies.

  • Working knowledge of code level review, software logic review, black box testing, and system validation.

  • Strong interpersonal skills

  • Ability to analyze and optimize manufacturing and quality systems

  • Product, design & prototyping

  • Ability to create and provide training

  • Software application skills

  • Problem solving ability

  • Ability to create, review and coordinate test protocols and reports

  • Ability to generate engineering proposals

  • Oral and written presentation skills

  • Ability to Lead cross functional teams

  • Understanding of regulatory requirements

  • Ability to lead creation of risk management files

Education and Experience Required:

  • A minimum of a Bachelors degree in a technical field.

  • 3-5 years (Master’s degree plus zero to three years) of engineering or Quality engineering experience within the medical device or equivalent industry.

Physical Demands:

While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment:

  • Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

  • While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Primary Work LocationUSA AZ - Tempe Headquarters

Additional Locations

Work Shift

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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